PRGM BI75000022 OARM ADDITIONAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PRGM BI75000022 OARM ADDITIONAL manufactured by Medtronic Navigation, Inc (littleton).

Event Text Entries

[185767453] Patient information unavailable at the time of filing. A manufacturer representative went to the site to test the imaging system. The manufacturer representative found blown 600v 6a fuse on stand alone board. Replaced fuse and performed system checkout with no more issues. System is functioning as intended so returned to service. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185767514] Medtronic received information regarding an imaging system used during a sacroiliac and thoracolumbar procedure. It was reported that the site could not shoot x-ray and that the system was stuck in initializing please wait. Multiple reboots no fix. Used the o2 for the case. There was a delay of less than 1 hour. No patient impact was correlated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004785967-2020-00428
MDR Report Key9902598
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2015-04-17
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC (LITTLETON)
Manufacturer Street300 FOSTER ST
Manufacturer CityLITTLETON MA 01460
Manufacturer CountryUS
Manufacturer Postal Code01460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRGM BI75000022 OARM ADDITIONAL
Generic NameIMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Product CodeOXO
Date Received2020-03-31
Model NumberBI75000022
Catalog NumberBI75000022
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC (LITTLETON)
Manufacturer Address300 FOSTER ST LITTLETON MA 01460 US 01460


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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